Positive results for Amgen’s Phase 3b LIBERTY study assessing the efficacy of Aimovig

Amgen affirms optimistic outcomes for Phase 3b LIBERTY study evaluating the efficacy and safety of Aimovig (erenumab) 140 mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures. The study satisfied its primary endpoint with more patients taking Aimovig experiencing a 50% reduction from baseline in their monthly migraine days as compared to Placebo. The study also managed to satisfy secondary endpoints, including reduction of monthly migraine days, reduction in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 75 percent and 100 percent responder rates (number of patients experiencing at least a 75 percent or 100 percent reduction in monthly migraine days compared to placebo.

Aimovig is designed to selectively block the calcitonin gene-related peptide (CGRP) receptor thereby activating migraine. Aimovig was the first investigational therapy targeting the CGRP pathway to receive U.S. Food and Drug Administration (FDA) and European Medicines Agency regulatory filing acceptance. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018. If approved, Novartis and Amgen will co-commercialize Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis possesses rights to commercialize in rest of world.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said “These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig. We look forward to working with regulators to bring the first preventive option specifically developed for migraine to patients worldwide.”

Image Source- Amgen